FDA Medical Device Recalls (openFDA)
Spacelabs Healthcare Inc: Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.
- Recall number
- Z-2077-2014
- Recalling firm
- Spacelabs Healthcare Inc
- Product
- Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.
- Status
- Terminated
- Initiated
- 2014-06-18
- Posted
- 2014-07-17
- Terminated
- 2014-12-08
- Reason
- With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
- Root cause
- Process control
- Action
- Spacelabs sent an Urgent Medical Device Correction letter dated June 20, 20/14 to all affected customers. The letter identified the affected product, problem and the actions to be taken. Customers are informed that Spacelabs Field Service personnel will be contacting their facility to schedule a convenient time to confirm, at no cost, a software update is needed to resolve this issue. Customers with questions are instructed to contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
- Quantity
- 8 units total (3 units in US)
- Distribution
- Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.
- Lot, serial or model codes
- Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209
- 510(k) numbers
- ["K112173"]
- PMA numbers
- not on file
- Product code
- CBR
- Firm FEI
- 3010157426
- Firm city
- Snoqualmie
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28